Levels of Review Flashcards
(9 cards)
Exempt from IRB Review
IRB Review and Oversight not needed.
Limited IRB Review
IRB Review specifically for privacy, confidentiality, and broad consent (if applicable). Adheres to exempt requirements.
Expedited Review
Minimal Risk research that meets specific requirements. One reviewer instead of a full panel, but full IRB approval criteria is followed. Lots of things fall under this category outside of full study approval (like how we approve new sites under previously approved protocols via expedited).
Full Committee Review
More than minimal risk, requires a majority vote by a quorum, full IRB approval criteria must be met, at least annual renewal is needed.
Where are the Exempt Categories located?
45 CFR 46.104(d)
Per the Common Rule, how often are the expedited review categories evaluated?
at least every 8 years
How many exempt categories are there?
8
Where are the Expedited Categories located?
In the 1998 OHRP guidance/list, not in the common rule directly
How many expedited categories are there?
9
